Regulatory Officer

Our client, specialising in the distribution of pharmaceuticals and medical products, representing a broad portfolio of international brands and is recognised for its reliability, regulatory compliance, and efficient supply chain management is looking for a Regulatory Officer

The Main Responsibilities include: 

• Prepare and submit regulatory documentation (applications, renewals, variations, PSURs/PBRERs, labelling notifications) in a timely manner.
• Maintain accurate records, databases, and correspondence, ensuring easy accessibility.
• Keep updated on EU Directives and regulatory requirements; prepare reports as needed.
• Liaise with the Medicines Authority, the Responsible Person, and overseas regulatory counterparts; attend meetings, seminars, and training (locally or abroad).
• Check artwork and labelling of products prior to release, including materials for over-labelling and repackaging.
• Support the Responsible Person with tenders, self-inspections, supplier warehouse audits, and temperature record reviews.
• Assist with psychotropic drug orders (if registered pharmacist), stock transfers from quarantine to saleable status, and approval of returned goods.
• Demonstrate strong organisational and time management skills in all tasks.

Working Hours:

8:00-16:30 or 8:30-17:00

Requirements

• Proficient in Computing Skills
• Organised
• Fluent in both Maltese & English

Education and Experience

• Degree in Pharmacy, Pharmaceuticals or a similar degree is a must

Benefits

• 10 free sessions with Richmond Foundation
• Health Insurance
• The company provides a sick bank benefit, offering support for employees who require surgery or extended recovery time, after the probation period

Job Reference: HY208